Course overview
Designed to equip you with the knowledge and skills necessary to excel in inspections by major health authorities, including the FDA, MHRA, PIC/S, ANVISA, WHO, and EMA, this training course serves as a pathway to mastering international health authority inspections and setting your organisation up for success. In today's global marketplace, pharmaceutical companies, healthcare organisations, and manufacturers must navigate complex regulatory landscapes to ensure product safety, quality, and compliance.
Whether you are preparing for your first inspection or seeking to enhance your existing compliance strategies, this training course offers actionable insights to help you pass international inspections with confidence. It focuses on understanding the specific requirements of each health authority and the best practices to meet their expectations.
By the end of this course, you will be empowered to manage inspections effectively, proactively address potential compliance issues, and maintain continuous readiness for audits. Our goal is to ensure you are fully prepared to navigate regulatory inspections and uphold the highest standards of quality and safety in your operations.
CPD Hours: 12
Course Content
- Day 1
- Introduction to regulatory inspections
- Preparing for audits: key principles
- Understanding FDA inspections
- Understanding MHRA and EMA inspections
- Understanding PIC/S and WHO inspections
- Workshop - how to respond to FDA 483s
- Day 2
- Understanding ANVISA inspections
- Inspection communication and interaction with inspectors
- Workshop - problems between PIC/S and other health authorities
- Preparing for inspections: simulation and role play
- Remote inspections and audits
Speakers
Mustafa Edik
Mustafa Edik is a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.
As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.
His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.
Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:
- GMP/GDP audits and supplier qualification
- Validation, qualification, and quality risk management (ICH Q9)
- Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
- Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
- Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
- Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards
Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.
A prolific author, Mustafa's works include:
- “Sorularla GMP Dokümantasyonu” - a practical guide to GMP documentation
- “GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) - a comprehensive reference on effective GMP auditing practices
Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.
